SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

Prior treatment

• Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.
• Prior thoracic radiotherapy.
• Active serious infection prior to first dose, including active infection, active tuberculosis, HIV positivity, active hepatitis B or C, or known active syphilis.
• Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known allergy to any component of the investigational drug(s), or history of severe hypersensitivity reaction to any monoclonal antibody.

Other illness

• Imaging evidence during screening showing tumor invasion of major blood vessels, invasion of critical surrounding organs, or risk of tracheoesophageal fistula or esophagopleural fistula as assessed by the investigator.
• History of hypertensive crisis or hypertensive encephalopathy, or uncontrolled hypertension despite medication.
• Active autoimmune disease or a history of autoimmune disease with a risk of recurrence.
• Bleeding tendency, high bleeding risk, or coagulation disorders.
• Other malignancies.
• History of non-infectious pneumonia requiring systemic corticosteroid therapy or current interstitial lung disease.
• Known alcohol or drug abuse, psychiatric disorders, or history of illicit drug use.
• Any other condition deemed unsuitable for enrollment by the investigator.

Other

• Symptomatic central nervous system metastases.
• Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Participation in another clinical trial, except for follow-up in observational (non-interventional) studies or follow-up phases of interventional studies.
• Pregnant or breastfeeding women.

• Voluntary written informed consent (ICF) signed prior to screening.
• Age ≥18 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival ≥3 months.
• Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and is not suitable for definitive concurrent or sequential chemoradiotherapy, according to the 9th edition of the TNM staging system by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).
• For subjects with adenocarcinoma, non-smokers, or squamous cell carcinoma with mixed adenocarcinoma components, absence of sensitizing EGFR mutations (e.g., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I) or ALK gene rearrangements must be confirmed by tumor tissue, cytology, or blood samples prior to enrollment.
• Availability of tumor tissue samples for PD-L1 testing.
• No prior systemic anticancer therapy for the study disease.
• At least one measurable lesion (excluding brain lesions) per RECIST v1.1. 10 Adequate organ function.